Snr QA/RA Specialist (MNC)

PEOPLE PROFILERS PTE. LTD.; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

PEOPLE PROFILERS PTE. LTD. is seeking a Regulatory Affairs professional in Singapore to manage MFDS registrations, quality systems and regulatory compliance across the product lifecycle.

You will lead submissions, monitor regulatory changes, support distribution teams with technical data and maintain ISO 13485 practices, including internal audits and supplier inspections.

Qualifications

• Bachelor’s degree in Science, Lifescience, or Engineering with 3–5 years regulatory/quality experience in medical devices.
• Knowledge of ASEAN Medical Device Directive, US FDA medical device regulation, or EU MDR is advantageous.
• Strong understanding of Technical Files and product registration process.
• ISO 13485 familiarity with internal auditor certification.
• Excellent technical report writing skills.

Responsibilities

• Lead preparation and submission of MFDS registrations to ensure timely approvals.
• Manage MFDS license renewals, variations and documentation updates.
• Review marketing materials and product labels for MFDS compliance.
• Monitor regulatory landscape and inform Regional HQ of trends.
• Support distributors and sales teams with technical product data.
• Maintain QMS per MFDS and corporate policy; lead internal training initiatives.
• Conduct internal audits and 3PL warehouse inspections for readiness.
• Handle local product quality complaints and coordinate investigations with Regional QA.
• Oversee 3PL activities with Supply Chain ensuring deviations are addressed.

Skills

Regulatory affairs

Quality management

Audits & inspections

Technical report writing

Education

Bachelor’s degree in Science/Life science/Engineering

Job description

Key Responsibilities:

Regulatory Affairs:

• Product Registration:Lead the preparation and submission of KGMP and product registration dossiers to the Ministry of Food and Drug Safety (MFDS), ensuring timely approvals.

• Compliance & Maintenance:Manage license renewals, variations, and updates to the MFDS. Maintain accurate records in our Regional HQ databases and ensure all product documentation is current.

• Labeling & Advertising:Review and approve marketing materials and product labels to ensure they align with MFDS-approved claims and regulatory standards.

• Strategic Monitoring:Monitor the regulatory landscape for new requirements, assessing business impact and keeping Regional HQ informed of emerging trends.

• Stakeholder Support:Act as a key regulatory advisor, supporting distributors and sales teams with technical product data.

Quality Management & Assurance:

• System Management:Maintain and enhance the Quality Management System (QMS) in compliance with MFDS regulations and corporate policies. Lead internal training initiatives to foster a culture of quality.

• Audits & Inspections:Conduct internal audits and manage 3PL warehouse inspections to ensure seamless readiness for regulatory body evaluations.

• Complaint Handling:Manage local product quality complaints, collaborating with Regional QA teams to drive timely investigations and resolutions.

• Supply Chain Oversight:Partner with local Supply Chain to oversee 3PL activities, including incoming inspections and deviation/reworks, ensuring strict adherence to Regional procedures.

Requirements:

• Bachelor’s degree in Science, Lifescience, Engineering with 3 - 5 years of regulatory, reimbursement, quality management system and quality experience in medical device company.
• Knowledge in ASEAN Medical Device Directive, US FDA medical device regulation or EU Medical Device Regulation would be advantageous.
• Must have good knowledge and understanding of Technical Files and product registration process.
• Familiar with design and development, manufacturing testing in order to understand the technical reports for product registration submission.
• Familiar with standard related to Quality Management Systems (ISO 13485) with internal auditor certification.
• Good Technical report writing skills.
• 1 year direct contract with full benefits.
• JOBID:JOB-00544

All Successful candidates can expect a very competitive remuneration package and a comprehensive range of benefits.